Law Updates

Subject

Summary: The Directorate General of Trade Remedies (DGTR) has initiated an anti-dumping investigation into imports of Sodium Nitrite from China PR. The investigation was officially initiated on 23 June 2026 under Case No. AD (OI)-034/2026, and published in the Gazette of India. The purpose of this investigation is to examine whether Sodium Nitrite is being imported into India at unfairly low prices and whether these imports are causing harm to Indian manufacturers. If the DGTR finds evidence of dumping and injury to the domestic industry, anti-dumping duties may be imposed. The decision could affect importers, domestic producers and businesses that use Sodium Nitrite as a raw material, making it important for stakeholders to understand the scope and possible impact of the investigation. About the Product: Sodium Nitrite (SNI) Sodium Nitrite is an industrial chemical sold in solid or liquid form. It is a white to slightly yellowish crystalline powder, granular, flake or briquette solid, highly water-soluble and hygroscopic. It is classified under Customs Tariff Chapter 28, sub-heading 28341010. It has wide industrial applications: Metal treatment and surface finishing: heat treatment of metals, corrosion inhibitors in water systems Rubber and polymer industries- anti-corrosion compound Dyes and textiles- diazotisation reactions Pharmaceuticals- intermediate chemical Food industry- food preservation (regulated usage) Construction- concrete antifreeze admixtures in cold climates Agriculture- fertiliser and pesticide formulations SNI has no commercially interchangeable substitute chemical under the same name; this makes every industry that uses it either dependent on domestic producers or on imports. Investigation Date and Background Initiation date: 23 June 2026, New Delhi Case reference: AD (OI)-034/2026 Filed by: Deepak Nitrite Limited (DNL), supported by Kutch Chemical Industries Limited Subject country: China PR (People's Republic of China) Period of Investigation (POI): 1 April 2025 to 31 March 2026 (12 months, as extended by DGTR from the applicant's proposed 9-month POI) Injury period examined: 2022-23, 2023-24, 2024-25 and POI 2025-26 Other domestic producers in India identified in the filing: National Fertilizers Limited Punjab Chemicals & Pharmaceuticals Limited Rashtriya Chemicals and Fertilizers Limited Notably, Rashtriya Chemical Industries Limited has already shut down SNI production due to unviability caused by cheap Chinese imports a key piece of prima facie evidence cited in the application. Why DGTR Initiated This Investigation The DGTR initiated the investigation after receiving allegations that imports of Sodium Nitrite from China PR were being dumped into the Indian market, causing financial harm to domestic manufacturers. Based on the information submitted by the applicant and supporting producers, the authority found sufficient evidence to examine the matter further. The Alleged Core Problem The applicant and supporting domestic producers alleged that: 1. Chinese exporters are selling SNI in India below their cost of production or below the normal value. This is the definition of "dumping" under WTO/AD Rules. 2. Imports of SNI from China have increased in both absolute volume and relative market share during the injury period. 3. Chinese imports are undercutting domestic prices, selling at prices lower than what Indian manufacturers need to charge to remain viable. 4. The domestic industry has consequently suffered: Decline in production and sales volumes Losses, cash losses, and negative return on investment during the POI Price depression: Indian producers are being forced to lower prices to compete with cheap imports 5. One major domestic producer (Rashtriya Chemical Industries Limited) has shut down SNI production entirely because it was no longer financially viable in the face of cheap Chinese imports. Normal Value Determination Challenge China PR is being treated as a non-market economy per Article 15(a)(i) of China's WTO Accession Protocol. This means Chinese producers cannot simply submit their own cost data to establish normal value they must prove that market economy conditions prevail in their industry. The applicant attempted to use EU import prices as a benchmark for normal value, but EU imports were found to be only 1% of total India imports during POI, making this methodology unreliable. Therefore, DGTR has determined normal value based on prices paid/payable in India with adjustments for selling, administrative expenses and profit a methodology open to challenge by all interested parties. Prima Facie Dumping Margin The comparison of normal value and export price at ex-factory level shows the dumping margin is above the de-minimis level and is significant a threshold required by law to proceed with an investigation. How the DGTR Investigation Will Affect Businesses and Compliance Requirements Businesses involved in importing, exporting or manufacturing Sodium Nitrite should closely follow the investigation and ensure timely compliance with all DGTR requirements. Phase-1: During the Investigation (Now to approximately June 2027) Parties have 37 days from the date DGTR circulates the non-confidential version of the application on the SETU portal (or transmits it to China's diplomatic representative) to file questionnaire responses. All parties must: Register on the SETU portal (https://setu.dgtr.gov.in) under Case AD (OI)-034/2026. Submit both Confidential Version (CV) and Non-Confidential Version (NCV) of all responses, each uploaded in separate designated columns. Narrative submissions must be in searchable PDF or MS Word format, and data files in MS Excel format. Clearly mark every page as "Confidential" or "Non-Confidential"; unmarked submissions are treated as non-confidential. Comments on PUC/PCN (product under consideration/product control number) methodology can be submitted within 15 days of initiation. Extension requests must be filed at least one day before the original deadline; extensions beyond 15 days are rarely granted. Phase 2: If Anti-Dumping Duty Is Imposed If DGTR finds that dumping is proven and the domestic industry is materially injured, it recommends an anti-dumping duty to the Central Government. Businesses will then: Indian importers must pay additional customs duty (anti-dumping duty) on SNI imports from China on every consignment. Downstream users must factor the new cost structure into their procurement and pricing strategies. Domestic manufacturers benefit from the protection and may price competitively with duties factored in. Who Will Benefit If Anti-Dumping Duties Are Imposed? If the investigation confirms dumping and anti-dumping duties are imposed, several stakeholders across the industry could benefit. Indian Sodium Nitrite Producers Direct and Biggest Winners Deepak Nitrite Limited (DNL) and Kutch Chemical Industries Limited, the applicant and supporter, stand to benefit most directly. If anti-dumping duty is imposed, they can compete more fairly on price and recover market share. National Fertilizers Limited, Punjab Chemicals & Pharmaceuticals Limited, and Rashtriya Chemicals and Fertilizers Limited can also benefit. Rashtriya Chemical Industries Limited may even consider restarting production if the market becomes viable again. India's overall SNI manufacturing capacity gets protection, preserving industrial jobs, capital investment, and technology. Indian Chemical Industry Ecosystem (Indirect Benefit) Domestic SNI supply security is strengthened. Industries dependent on SNI dye manufacturers, textile processors, rubber compounders, pharma intermediates, and food preservative suppliers benefit from having a viable domestic supply base rather than being entirely dependent on a single source country. Government of India Strategic Benefit Reducing extreme dependence on Chinese imports for an industrial chemical supports India's broader Aatmanirbhar Bharat (self-reliance) and supply chain resilience goals. Preventing the destruction of domestic chemical manufacturing capacity avoids the costly and slow process of rebuilding it later if geopolitical tensions disrupt Chinese supply. Who Is Negatively Impacted or Faces Losses While the investigation aims to protect domestic manufacturers, some businesses may face higher costs and operational challenges if anti-dumping duties are imposed. Indian Importers and Trading Companies Importing from China Companies that built their businesses around sourcing cheap Chinese SNI will face higher procurement costs if an anti-dumping duty is levied. Their pricing to customers will need to be revised upward, which could affect margins and contracts. Indian Downstream Industries that Consume SNI Rubber, textile dye, pharma intermediate, food preservation and construction chemical manufacturers who used cheap Chinese SNI as a raw material will see input cost increases. Smaller downstream users who cannot pass on input costs to their own customers may see margin compression. Construction companies using SNI as a concrete additive in cold-climate projects may see slightly higher material costs. Chinese Exporters of Sodium Nitrite If anti-dumping duty is imposed, Chinese SNI exports to India, currently their largest or a major market by volume, will become significantly less price-competitive or potentially unviable. This represents a meaningful market access loss for Chinese chemical companies. Chinese Government (Diplomatic Concern) India is increasingly using the anti-dumping mechanism for a growing range of Chinese industrial chemicals. Each such investigation creates diplomatic friction and adds to the list of trade barriers between the two countries. Impact on India's Economy The outcome of the investigation could have wider economic implications beyond the Sodium Nitrite industry. Positive Effects If anti-dumping duties are imposed after the investigation, India could benefit in several important ways: Preservation of Domestic Manufacturing: The chemical industry, especially speciality industrials like SNI, is foundational to many downstream industries. Protecting domestic capacity prevents industrial hollowing-out. Jobs and Investment: Anti-dumping duty, if imposed, directly saves jobs at DNL, Kutch Chemical, and potentially across the industry, including at those companies that paused production. Revenue Neutrality or Benefit: Anti-dumping duties collected go to the Central Government as customs revenue. Supply Chain Resilience: Reducing import concentration from one country improves India's industrial security, especially relevant given the ongoing strategic sensitivity in India-China trade relations. Negative / Cautionary Effects Short-term cost increase- for industries consuming SNI as raw material this is a real inflationary pressure for chemicals, food preservation, construction, dyes and rubber sectors. Higher costs to downstream exporters: Indian exporters of dyes, textiles, rubber goods and pharma products who use SNI may temporarily face a higher cost base, slightly reducing their international price competitiveness. If the investigation is prolonged or inconclusive, market uncertainty over import pricing harms procurement planning for all users. Impact on China's Economy Chinese SNI producers face market access risk in one of their major export destinations, which may redirect supply to other markets, pushing down prices globally. China may formally contest the investigation through its embassy in India (which has been separately notified) or potentially file a WTO dispute challenge if duties are ultimately imposed. For individual Chinese chemical exporting firms that are heavily reliant on India as an export market, this investigation represents a direct business threat. This also adds to the broader pattern of India reducing China-dependency in industrial chemicals, which, over time, could materially affect Chinese chemical export volumes globally. Is This a Right Decision? Based on the information available so far, the investigation appears to follow India's established legal framework for addressing unfair trade practices. Why this is the right and legally sound decision Anti-dumping is a WTO-recognized, rules-based trade remedy. India is entitled and legally correct to use it when there is prima facie evidence of dumped imports causing material injury. The evidence in this case is substantial: a major domestic producer has already shut down production, the applicant has provided data showing losses, cash losses, negative ROI, volume increases, and price undercutting all the key legal requirements for initiating an investigation. Treating China as a non-market economy under China's WTO Accession Protocol Article 15(a)(i) is a legally permitted and commonly used basis in anti-dumping investigations globally. India is within its rights here. The investigation follows a fully transparent, multilateral, rules-based process with questionnaires, hearings, confidential and non-confidential filings, public file access, and appellate remedies. Areas That Require Careful Consideration While the investigation is legally justified, its outcome should strike a balance between protecting domestic manufacturers and maintaining healthy market competition. Anti-dumping duty must be calibrated carefully excessive duty that makes SNI imports unviable could create a domestic monopoly situation with supply shortages and price gouging. DGTR must ensure the domestic industry is genuinely efficient and not simply seeking protection for non-competitive production methods. The investigation must be completed within the statutory 12-month period (extendable to 18 months), as prolonged uncertainty is damaging for all supply chain participants. On balance, this is a correct and legally justified trade protection action that is firmly pro-domestic-industry and consistent with India's industrial policy, its WTO rights and its goal of building resilient domestic chemical manufacturing capacity. How This Investigation Improves Conditions, Transparency and Industry Health Beyond addressing unfair trade practices, the investigation can also strengthen transparency, regulatory compliance and the long-term stability of India's chemical industry. The SETU portal mandate ensures all filings are digitally traceable, publicly accessible (for non-confidential portions) and auditable, vastly improving transparency over older paper-based anti-dumping processes. The requirement to submit both confidential and non-confidential versions prevents any party from hiding commercially critical information behind spurious confidentiality claims. If anti-dumping duty is imposed, Indian SNI manufacturers get a level playing field to invest, expand capacity, and improve process efficiency and lower costs benefiting downstream users over the medium term. The investigation deters further aggressive below-cost pricing by Chinese exporters not just of SNI but signals to the broader chemicals sector that India will use trade remedies consistently. Opportunities for Corpseed This investigation and any resulting anti-dumping duty regime create several distinct service opportunities: 1. Anti-Dumping Advisory for Indian Importers and Users Help companies that currently import SNI from China prepare SETU portal submissions, file questionnaire responses, and argue for lower duty or exclusion based on specific end-use applications. Many smaller importers and industrial users will not know how to engage with the DGTR process; Corpseed can act as their representative. 2. Domestic Producer Support Services Assist DNL, Kutch Chemical, National Fertilizers, Punjab Chemicals and others in marshalling production, injury and pricing data for DGTR questionnaire responses to strengthen the case for anti-dumping duty. 3. Supply Chain Transition Advisory If duty is imposed, help downstream SNI users (rubber, dye, textile, pharma, food, construction sectors) transition to domestic sourcing, identifying suppliers, evaluating prices, and qualifying domestic SNI for their processes. 4. Alternative Sourcing Advisory For users who cannot switch entirely to domestic supply, identify alternative import sources outside China (EU, Japan, South Korea, Middle East) and assess landed cost under alternative sourcing scenarios. 5. Anti-Dumping Monitoring Service Create a subscription alert service for businesses across chemicals, metals and other industries that tracks all DGTR AD investigations, preliminary findings, duty impositions, sunset reviews and safeguard investigations, giving clients advance notice to manage procurement. 6. PCN Methodology and Product Scope Comments Firms with specific SNI grades or formulations may want to argue that their product is outside the PUC scope. Corpseed can file PCN scope comments on behalf of such firms within the 15-day window. 7. Regulatory Compliance Training Run workshops for chemical industry procurement, legal and finance teams on how anti-dumping investigations work, what SETU portal filings require and how to manage the compliance calendar during a DGTR investigation.

Subject

Summary: WDRA’s June 2026 notification expands the list of commodities that can be stored in registered warehouses and covered under the regulated, negotiable warehouse receipt ecosystem. It’s a pro‑business, pro‑farmer, and pro‑logistics move that modestly increases compliance requirements but mainly improves market access, credit, and quality assurance. What does the WDRA Notification actually do? In a significant regulatory update, the WDRA has expanded the list of commodities eligible for storage in registered warehouses, promoting standardized warehousing and greater participation in the e-NWR ecosystem. 1. Authority: Warehousing Development and Regulatory Authority (WDRA), under the Warehousing (Development and Regulation) Act, 2007 and the Registration of Warehouses Rules, 2017.  2. Notification date: 16 June 2026, published in Gazette CG‑DL‑E‑27062026‑273885.  3. Scope: WDRA determines that the following additional agricultural and non‑agricultural (non‑metal) commodities may be stored in registered warehouses (in addition to those already notified):  Table 1- Agricultural commodities Karchura (Curcuma zedoaria) Chia seeds Mango pulp Roasted chicory powder Kalonji (Nigella) Mahua flower Table 2- Non‑agricultural commodities (other than metals) Diammonium phosphate (DAP) Rock phosphate Magnesium sulphate 4.  All these commodities, when stored in registered warehouses, must comply with AGMARK, BIS, FSSAI, or eNAM quality standards; if no such standards exist, Central/State Government or government‑body standards apply.  5.  Chemical or allied lab testing, when required, must be done only in AGMARK labs, NABL‑accredited labs, and labs recognized by BIS, FSSAI, or Central/State Governments. This means these commodities can now participate more fully in the formal, regulated warehousing and negotiable warehouse receipt (NWR/e‑NWR) ecosystem. Why did WDRA come up with This Policy? The WDRA’s mandate is to create a transparent, quality‑linked warehousing system with negotiable receipts to support: Farmers and Agri‑traders: better storage, better prices, access to collateral‑based finance. Industry and fertilizer supply chains: structured, quality‑assured storage for input commodities. Adding these specific commodities responds to: 1. Market evolution Rising production and trade in chia seeds, kalonji, mango pulp, mahua flower, roasted chicory, many of which are niche/high‑value or export‑oriented. Growing reliance on DAP, rock phosphate, and magnesium sulphate in fertilizer blends and soil nutrition. 2. Need for formal, quality‑linked storage and financing. Farmers, FPOs and processors in these commodity chains need warehousing where banks and NBFCs accept receipts for loans. National agricultural market priorities (eNAM, Agri‑value chains) Allowing the WDRA‑registered warehousing and receipts for these commodities strengthens market integration and price discovery. 3. Standardisation and risk management WDRA wants clear standards and lab testing for commodities that can otherwise be highly variable in quality (e.g., mango pulp, mahua flower, DAP). So, the notification is about bringing more commodities under the umbrella of regulated warehousing, quality standards and finance‑linked receipts, not about restricting trade. How Will Businesses Comply with the New Regime? For warehouses seeking or holding WDRA registration, and for businesses using them, compliance involves: 1. Commodity scope and registration WDRA‑registered warehouses can now apply to store these newly added commodities, subject to WDRA’s technical and infrastructure criteria (e.g., food‑grade facilities for mango pulp, proper handling for fertilizers). Existing registered warehouses must update their commodity lists with WDRA if they wish to store these items. 2. Quality standards compliance For each commodity, warehouses and depositors must ensure storage and documentation meet AGMARK/BIS/FSSAI/eNAM standards, if available for that commodity.  If no such national standards exist, follow the Central/State Government or government‑body quality norms. This typically means: Defined grade parameters (moisture, purity, contaminants, etc. Standard operating procedures for sampling, testing, and certification. 3. Lab testing and certification Where chemical or allied analysis is needed (e.g., DAP nutrient content, mango pulp parameters), only these labs can be used: AGMARK labs NABL‑accredited labs notified for testing/calibration. Labs recognised by BIS, FSSAI, or Central/State Governments Warehouses and depositors must maintain test reports and certificates to support warehouse receipts and potential disputes. 4. Warehouse receipt issuance Once commodities and warehouses are compliant, the warehouse can issue negotiable warehouse receipts (NWR/e‑NWR) for these commodities, which banks and NBFCs can accept as collateral. Businesses must ensure that: Commodity identity, grade, and quantity on the receipt match lab reports and inventory records. Receipts are issued and transferred only through WDRA‑recognised systems (e‑NWR). Who Gains the Most? The notification creates benefits across the commodity value chain by improving access to regulated warehousing, quality assurance, and warehouse receipt financing for multiple stakeholders. Farmers, FPOs and small traders in these commodity chains Producers and FPOs dealing in chia seeds, kalonji, mahua flower, mango pulp, chicory, karchura can now store in WDRA‑registered warehouses, obtain quality‑certified receipts, and use them to: Get warehouse‑receipt‑based loans Delay sales until prices improve (reducing distress selling) Enter organised markets and export supply chains more easily. Agri‑processors and exporters Mango pulp processors, spice and herb exporters, and beverage and functional food manufacturers gain from: Better quality‑assured storage, traceability, and documentation. Easier access to working‑capital finance using stored inventory as collateral. Stronger brand positioning using AGMARK/BIS/FSSAI standards. Fertiliser manufacturers and distributors Being able to store DAP, rock phosphate and magnesium sulphate in WDRA‑registered warehouses: Improves inventory management and financing (especially for peak‑season build‑up). Provides quality assurance (lab testing of nutrient content and contaminants) linked to national standards. Banks, NBFCs and agri‑fintechs More commodities under WDRA mean: Broader collateral universe for warehouse‑receipt finance products. More structured risk assessment, thanks to recognised labs and standard quality norms. Who Might Be Negatively Impacted or Face Losses While the notification creates significant opportunities for compliant businesses, it also increases regulatory expectations for entities operating outside the formal warehousing ecosystem. Unregistered or sub‑standard warehouses Warehouses that continue to operate outside the WDRA system will find it harder to attract clients in these commodities: Banks may prefer receipts from warehouses registered with the WDRA. Major exporters and purchasers may require WDRA-linked quality assurance.  Traders relying on informal storage and opaque quality claims Traders or intermediaries who previously exploited information asymmetry (e.g., under‑grading farmer produce or mislabelling fertiliser quality) will lose some advantage as: Lab testing and national standards become the norm. Buyers gain more confidence in WDRA receipts than in informal claims. Non‑compliant fertiliser dealers Fertiliser dealers who handled the low‑grade or adulterated DAP, rock phosphate, or magnesium sulphate outside any standard may find: Higher compliance costs (lab testing, standards). Reduced ability to sell substandard material without detection. Overall, the “losers” are mostly informal, non‑compliant actors mainstream businesses benefit from more predictability and access to finance. Impact on the Indian Economy By expanding the scope of regulated warehousing, the notification is expected to strengthen India's agricultural and commodity markets, with long-term benefits for financing, quality assurance, and supply chain efficiency. Positive economic effects 1. Better price realisation and reduced wastage Quality‑linked storage and receipts that encourage the farmers and processors to store properly and sell when prices are favourable, improving income and reducing wastage (especially for mango pulp and mahua flower). 2. Improved access to credit Expanding the commodities that are eligible for WDRA‑linked warehouse receipts broadens the formal credit ecosystem: More farmers and agri‑processors can borrow against stored stock. Fertiliser supply chains can smooth cash flows. 3. Quality upgrade and export boost AGMARK/BIS/FSSAI/eNAM standards and recognised lab testing improve the average quality, which: Supports export competitiveness for niche products (chia, kalonji, mango pulp, chicory). Reduces issues around sub‑standard fertilisers harming productivity. 4. Strengthening Agri‑value chains This step also helps deepen organised value chains in spices, functional foods, beverages, and fertilisers, supporting long‑term rural and industrial growth. Potential challenges For small warehouses and processors, there are higher compliance expenses (testing, documentation, registration fees), but they are reasonable and commensurate with the advantages. Short-term adjustment as informal players upgrade or leave in marketplaces where informal practices were prevalent, there may be some micro-level disruption.  Macro‑economically, this is a pro‑growth, pro‑quality, pro‑finance reform with only mild transitional friction. Is This the Right Decision or an Added Burden? Why It’s the Right Decision? It supports formalisation, quality assurance, and access to finance in sectors that were partly neglected, such as niche spices, functional foods, and key fertiliser inputs. It builds on successful WDRA use for grains and major commodities, widening the scope sensibly without adding heavy regulatory burdens. The notification leverages existing AGMARK, BIS, FSSAI, eNAM, and NABL infrastructures rather than creating new, overlapping rules for an efficient regulatory design. Where Burdens Exist Businesses and warehouses need to: When necessary, carry out lab testing and quality-control processes. Make sure that the paperwork complies with WDRA guidelines and national standards. Pay a portion of the registration and compliance fees.  These are real but largely manageable burdens, particularly compared to the business advantages. How the Policy Improves Conditions, Transparency and Environment/Safety? Conditions and transparency A clear listing of commodities and reliance on AGMARK/BIS/FSSAI/eNAM standards significantly improves market transparency: Clear, nationally recognised grades and specs. Standardised lab processes and recognised labs. WDRA registration and e‑NWR issuance make warehousing and trade more traceable and auditable, reducing disputes and fraud. Environment and safety For fertiliser inputs (DAP, rock phosphate, magnesium sulphate): Lab testing and standards also help to prevent adulteration and unsafe products that could harm soils and crops. Better storage practices reduce spillage, contamination, and handling risks. For food/Agri products (chia, mango pulp, kalonji, mahua, chicory): Quality standards reduce the risk of contamination, spoilage, and unsafe residues, improving food safety. So, while the notification is not primarily environmental legislation, it indirectly advances resource safety, soil health, and food safety through better quality control and storage practices. Opportunities for Corpseed This change opens several specific business lines for Corpseed: 1. WDRA Warehouse Registration & Commodity Expansion Services Help warehouses in Agri‑regions and fertiliser hubs register with WDRA, update commodity lists to include these new items, and meet infrastructure and documentation requirements. 2. Quality Standards and Lab Compliance Consulting For every newly added commodity, map the AGMARK/BIS/FSSAI/eNAM standards. Create SOPs for certificate administration, testing, documentation, and sampling. Communicate with labs that are recognized and accredited by NABL on behalf of clients. 3. Warehouse Receipt Finance Enablement Work with banks/NBFCs to create warehouse‑receipt finance products specifically for: Mango pulp processors Chia and kalonji traders Mahua collectors and processors Fertiliser stockists using DAP/rock phosphate/magnesium sulphate. Support clients in integrating e‑NWR systems into their operations. 4.  Commodity‑specific Advisory For mahua, kalonji, chia, chicory, provide end‑to‑end advisory: Quality standards Processing and storage best practices. Linkages to WDRA warehouses and agri‑finance. 5. Training and Capacity Building Conduct training programmes for warehouse managers, FPOs, processors and fertiliser dealers on: WDRA rules Quality grading Lab testing and documentation How to use warehouse receipts for finance. 6. Digital Tools Build lightweight tools that track: Commodity quality test schedules Receipt issuance and maturity Compliance with AGMARK/BIS/FSSAI/eNAM norms across lots and batches.

Subject

Summary: On 29th June 2026, the Central Board of Indirect Taxes and Customs (CBIC), under the Ministry of Finance (Department of Revenue), issued Notification No. 59/2026-Customs (N.T.) revising the tariff values for a range of commodities including palm oil, palmolein, soya bean oil, brass scrap, gold, silver, and areca nuts. This notification directly affects import valuation and customs duty calculation for businesses dealing in these goods. This guide explains the notification in simple, practical terms what it says, what has changed (or not), why tariff values matter, and how businesses should respond. The Regulatory Framework Customs duty on many bulk commodities in India is not always calculated on the actual transaction value declared by the importer. Instead, for certain notified goods, the government fixes a "tariff value," a benchmark value per unit (per metric tonne, per 10 grams, or per kilogram) under Section 14(2) of the Customs Act, 1962 (Act No. 52 of 1962). Duty is then calculated on this notified tariff value instead of the fluctuating market price, giving both the government and importers a predictable base for taxation. This system was originally established on 3rd August 2001. Since global commodity prices move constantly, CBIC reviews and revises these tariff values periodically, sometimes every two weeks, through fresh notifications. The current notification is one such periodic revision, replacing the tariff value tables that were last updated on 15th June 2026. What Has Changed? This notification substitutes Table-1, Table-2, and Table-3 of the original 2001 notification with revised tables covering palm oil, palmolein, soyabean oil, brass scrap, gold, silver, and areca nuts. Table-1 covers Crude Palm Oil, RBD Palm Oil, Other Palm Oil, Crude Palmolein, RBD Palmolein, Other Palmolein, Crude Soyabean Oil, and Brass Scrap. Table-2 covers Gold in various forms, Silver in various forms, Gold bars, Gold coins, and Gold findings. Table-3 covers Areca Nuts (Supari). The important part is that despite issuing a fresh notification, every single tariff value listed remains the same as in the previous notification. The document itself marks each entry with no change. For edible oils, Crude Palm Oil stays at US dollar1232 per Metric Tonne, RBD Palm Oil at US dollar 1238, Other Palm Oil at US dollar1235, Crude Palmolein at US dollar 1247, RBD Palmolein at US dollar 1250, Other Palmolein at US dollar 1249, and Crude Soyabean Oil at US dollar 1248 per Metric Tonne. Brass Scrap of all grades continues at US dollar 7814 per Metric Tonne. For precious metals, Gold availing benefits under Notification No. 45/2025-Customs remains at US dollar 1348 per 10 grams, while Silver under the same benefit notification stays at US dollar 1897 per kilogram. General silver, including semi-manufactured forms, also continues at US dollar 1897 per kilogram, and gold bars, gold coins, and gold findings remain at US dollar 1348 per 10 grams. Areca Nuts continue at US dollar 10785 per Metric Tonne. In short, this notification does not introduce any new value, rate, or category it simply reconfirms the existing tariff values through a fresh, legally current notification, replacing the reference to the older 15th June 2026 notification. This is standard CBIC practice: even when global prices remain broadly stable, CBIC formally re-notifies tariff values at each periodic review cycle so that importers, customs brokers, and assessing officers always have an up-to-date notification to rely on, rather than citing an outdated one. Table Goods Covered Table-1 Crude Palm Oil, RBD Palm Oil, Other Palm Oil, Crude Palmolein, RBD Palmolein, Other Palmolein, Crude Soyabean Oil, Brass Scrap Table-2 Gold (various forms), Silver (various forms), Gold bars, Gold coins, Gold findings Table-3 Areca Nuts (Supari) Actual Values in This Revision Here is the important part: despite the fresh notification, every single tariff value listed remains unchanged from the previous notification. The document itself marks each entry with no change. Item New Tariff Value Change from Previous Crude Palm Oil US dollar 1232 per Metric Tonne No change RBD Palm Oil US dollar 1238 per Metric Tonne No change Other Palm Oil US dollar 1235 per Metric Tonne No change Crude Palmolein US dollar 1247 per Metric Tonne No change RBD Palmolein US dollar 1250 per Metric Tonne No change Other Palmolein US dollar 1249 per Metric Tonne No change Crude Soyabean Oil US dollar 1248 per Metric Tonne No change Brass Scrap (all grades) US dollar 7814 per Metric Tonne No change Gold (Notification 45/2025 benefit) US dollar 1348 per 10 grams No change Silver (Notification 45/2025 benefit) US dollar 1897 per kilogram No change Silver (general/semi-manufactured) US dollar 1897 per kilogram No change Gold bars, coins, findings US dollar 1348 per 10 grams No change Areca Nuts US dollar 10785 per Metric Tonne No change Why re-notify if nothing has changed?  This is standard CBIC practice. Even when global prices remain broadly stable, CBIC formally reconfirms tariff values through a fresh notification at each review cycle. This keeps the legal reference point current and gives importers, customs brokers, and assessing officers a clear, up-to-date notification to cite instead of relying on an older one. Implementation Timeline/Norms This notification carries a specific, short-notice effective date: Date Event 15th June 2026 Previous tariff value notification (No. 55/2026) came into force 29th June 2026 Notification No. 59/2026 issued and published in the Gazette 30th June 2026 Notification comes into force The notification explicitly states it "shall come into force with effect from the 30th day of June, 2026," just one day after issuance. This is typical for tariff value notifications, which are issued on a fast, recurring cycle (roughly every two weeks) to keep pace with global commodity price movements, even when, as in this case, the values themselves don't move. Why This Was Implemented? CBIC's tariff value mechanism, and its periodic revision, exists for clear administrative and trade-facilitation reasons: Price stability check: Global prices of palm oil, soyabean oil, precious metals, and areca nuts fluctuate frequently. Periodic review ensures the notified tariff value doesn't drift too far from actual international market prices. Uniform duty assessment: Fixed tariff values also prevent under-invoicing or valuation disputes at different ports, ensuring the same duty base applies nationwide. Legal continuity: Even when values don't change, a fresh notification ensures customs officers and importers are always working from the latest or update, legally valid reference document rather than an outdated one. Revenue predictability: Both the government and the trade benefit from knowing duty will be calculated on a known, published value rather than a volatile, contestable transaction price. Alignment with recent linked notifications: The gold and silver entries specifically reference benefit conditions, showing CBIC keeps tariff values synchronized with other exemption and benefit notifications. Impact on Businesses Duty calculations remain unchanged- Since every tariff value in this notification is identical to the previous cycle, duty computation for palm oil, palmolein, soyabean oil, brass scrap, gold, silver, and areca nuts continues exactly as before.  No cost impact for importers- Businesses importing these goods will see no change in landed cost or duty outflow as a direct result of this notification.  Documentation reference must be updated- Import teams and CHAs need to cite Notification No. 59/2026-Customs (N.T.) instead of the superseded No. 55/2026 in all filings from 30th June 2026 onward.  Bill of entry accuracy matters- Any import cleared on or after 30th June 2026 should reflect the correct, currently applicable notification number, even though the values themselves haven't moved.  Gold and silver importers need cross-verification- Those claiming benefits under entries 194 and 195 of Notification No. 45/2025-Customs must ensure their documentation still correctly establishes eligibility, since the applicable tariff value depends on it.  Edible oil importers face no re-costing effort- Palm oil, palmolein, and soyabean oil importers can continue using existing costing templates without modification.  Brass scrap and areca nut importers see continuity- No adjustment needed to current duty computation practices for this cycle.  Ongoing monitoring still required- Since CBIC also revises tariff values roughly every two weeks, businesses must stay alert for the next notification, expected around mid-July 2026, as an actual revision could occur then.  Audit trail stays clean if references are updated correctly- Consistent citation of the latest notification avoids inconsistencies that could raise questions during customs audits or scrutiny. How Businesses Will Achieve Compliance Step 1: Update Reference Documentation Ensure your customs filing team, CHA (Customs House Agent), or import documentation is the current authority for tariff values from 30th June 2026 onward, replacing references to the superseded 15th June notification. Step 2: Verify Bill of Entry Filings For any import of the goods covered: palm oil, palmolein, soyabean oil, brass scrap, gold, silver, or areca nuts cleared on or after 30th June 2026, confirm that the bill of entry reflects the correct, currently applicable tariff value and notification reference. Step 3: Cross-Check Linked Notifications For gold and silver imports claiming benefits under entries 194 and 195 of Notification No. 45/2025-Customs, ensure your documentation correctly establishes eligibility for that benefit, since the tariff value applied depends on it. Step 4: Monitor the Next Revision Cycle Since CBIC revises these values roughly fortnightly, set up a simple internal tracking system (a shared calendar reminder or compliance checklist) to check for the next tariff value notification, expected around mid-July 2026. Step 5: Align Costing and Pricing Models Even though the values are unchanged this cycle, periodically cross-verify your internal costing sheets against the latest notified values to avoid all the errors accumulating from outdated references. Benefits for Businesses These are the advantages that businesses must get: Predictable duty costs: Unchanged tariff values mean importers can plan procurement and landed costs with continued certainty for this cycle. No re-costing effort is needed- existing duty calculation templates and costing models remain valid without modification. Reduced valuation disputes: A clear, government-notified value base minimizes the chance of disagreements with customs authorities over declared value. Easier compliance planning- Businesses can use the stability in this cycle to focus resources on other compliance priorities. Transparent benchmark for pricing: Downstream buyers and traders can rely on a known customs cost base when negotiating supply contracts. Simplified audit trail: Consistent values across two notification cycles make internal and external audits of import duty payments simpler to verify. Right Decision or Additional Burden? This particular notification is a routine regulatory action, not a policy shift, so the burden vs. benefit debate looks different here compared to a substantive rule change. In favour of this being a smooth, low-friction update The values themselves have not changed at all, so there is no real additional compliance cost, no need to revise pricing, and no impact on duty outflow. The only administrative task is updating the notification reference in paperwork, a minor, procedural step. The minor friction points Businesses and customs brokers must still track and cite the correct, current notification number each cycle. Missing this update, while unlikely to cause duty errors given unchanged values, could still create documentation inconsistencies during audits or scrutiny if the wrong (superseded) notification number is quoted. Overall view This is a routine, procedural notification that keeps the regulatory record current without creating any real additional burden for businesses. It must also reflect CBIC's systematic and transparent approach to tariff value management, which benefits trade predictability more than it costs businesses in compliance efforts. Business Opportunities Created Frequent tariff value notifications like this one create ongoing service opportunities for businesses supporting the import-export ecosystem: Customs compliance and documentation advisory firms are helping importers stay current with each notification cycle. Trade compliance software and automated tariff tracking tools that flag new CBIC notifications in real time Customs House Agents (CHAs) and clearing agents offering proactive value-verification services to clients Commodity trade advisory services help bulk importers of edible oils, metals, and areca nuts anticipate tariff value trends. Training and updates services for import-export teams to stay aligned with periodic CBIC notifications Businesses that build a reliable internal or outsourced system for tracking these fortnightly tariff value updates position themselves to avoid documentation errors and respond quickly whenever an actual value revision does occur. Corpseed's Core Message Not every regulatory notification signals a major change, and Notification No. 59/2026-Customs (N.T.) is a good example of that. The tariff values for palm oil, palmolein, soyabean oil, brass scrap, gold, silver, and areca nuts remain exactly where they were. Still, the notification itself is a reminder that customs valuation is a living, regularly reviewed system, not a one-time fixed rule. At Corpseed, our message to importers and customs stakeholders is straightforward: build a habit of tracking every CBIC tariff value notification, even when the values don't change. Staying current with the correct, latest notification reference protects your documentation from errors, keeps your compliance audit trail clean, and ensures that you're never caught off guard when an actual revision does happen. Treat routine notifications as an opportunity to keep your systems sharp, not as something to ignore until the numbers move.

Subject

Summary: On 23rd June 2026, the Food Safety and Standards Authority of India (FSSAI) notified the Food Safety and Standards (Licensing and Registration of Food Businesses) Second Amendment Regulations, 2026 in the Gazette of India. This notification brings two important changes for every food business in India, from big manufacturers to small shopkeepers. This guide breaks down the entire notification in simple language, explains what has actually changed, why it matters, and how your business can stay compliant without confusion. The Regulatory Framework Every food business in India, whether it makes food, packs food, stores food, or sells food, must follow rules made under the Food Safety and Standards Act, 2006. This is the main law that governs food safety in the country. Under this Act, FSSAI made the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011. These are the master rules that tell every Food Business Operator (FBO) what license conditions they must follow and what hygiene standards they must maintain. FSSAI has the legal power, under Section 92(2)(o) read with Section 31 of the Act, to amend these regulations whenever needed, with the Central Government's prior approval. That is exactly what has happened now. FSSAI followed the correct legal process: it first published a draft amendment on 23rd January 2026, invited objections and suggestions from the public and industry for 30 days from 27th January 2026, reviewed those responses, and only then issued the final, binding regulation on 23rd June 2026. This amends the original 2011 Regulations (notified 1st August 2011), which had last been amended on 10th March 2026. What Has Changed? The amendment touches two specific parts of the 2011 Regulations. Let's look at each one closely. 1. Daily Record-Keeping Condition (Schedule 2, Annexure 3 License Conditions) This is about Serial Number 8 under the "Conditions of License" list, which every licensed food manufacturer must follow. Earlier, this condition required maintaining daily records of production and raw material utilization. Now, it clearly requires these records to be maintained separately, meaning two distinct daily records instead of one combined entry. Importantly, this condition does not apply to non-manufacturing food businesses, so traders and distributors who don't manufacture anything are out of its scope. 2. Storage Rule for Raw Materials and Food Products (Schedule 4, Part II, Para 5.2.5) This is part of the general hygiene and sanitary requirements every FBO applying for a license must follow, under the "Food Operations and Controls" section. Earlier, the storage requirement was fairly general. Now, storage of raw materials, ingredients, work-in-progress, and processed/cooked/packaged food must strictly follow FIFO (First In, First Out) and FEFO (First Expired, First Out) principles. In simple words, the oldest stock and the stock closest to its expiry date must be used or sold first. This is a globally recognized food safety practice used to cut down on spoilage and wastage. This requirement does not apply to retailers. S. No. Where What Changed Who Is Exempted 1 Schedule 2, Annexure 3, Condition 8 Separate daily record of production and raw material use Non-manufacturing food businesses 2 Schedule 4, Part II, Para 5.2.5 Mandatory FIFO and FEFO storage system Retailers Implementation Timeline/Norms Unlike many regulations that give businesses a grace period of 6 months or a year, this amendment has no separate transition period. The notification clearly states it comes into force "on the date of their publication in the Official Gazette," meaning the rule is applicable from 23rd/24th June 2026 itself, the day it was published. Date Event 23rd January 2026 Draft amendment notified for public objections 27th January 2026 Draft made available to the public (30-day clock starts) Late February 2026 30-day objection/suggestion window closes 23rd June 2026 Final regulation notified in the Gazette Immediate Regulation comes into force, no additional waiting period What this means for businesses: There is no "wait and watch" option here. Since the regulation is already in force, food businesses covered under these provisions should start aligning their record-keeping and storage practices right away to avoid compliance gaps during FSSAI inspections or license renewals. Why This Was Implemented? FSSAI did not make this change randomly. There are clear, practical reasons behind both amendments: Better traceability of food: Separate records of production and raw materials make it much easier for FSSAI to trace back a food safety issue to its source, such as a specific batch of raw material. Reducing food wastage and spoilage- making FIFO/FEFO a formal requirement (instead of just a "good practice") ensures older or near-expiry stock is used first, cutting down food waste across the supply chain. Consumer safety: When expired or near-expired ingredients don't sit at the back of the storeroom while fresh stock is used first, the chances of expired food reaching consumers go down significantly. Reducing unnecessary burden on small players- FSSAI clearly built in exemptions: non-manufacturing businesses don't need the detailed production record, and retailers don't need to implement full FIFO/FEFO systems. This shows the intent was to target actual risk points rather than adding paperwork everywhere. Global alignment- FIFO and FEFO are internationally recognised food safety and quality management practices (used in HACCP and ISO 22000 systems), bringing Indian food regulations closer to global standards. Impact on Businesses The impact of this amendment is different depending on what kind of food business you run, so it helps to break it down by category. Food manufacturers feel the full weight of both changes. They must now maintain separate daily records of production and raw material utilization, and they must also reorganize their storage practices to follow FIFO and FEFO principles strictly. This means updating internal record formats, whether on paper registers or in digital/ERP systems, so that production data and raw material consumption data no longer sit together in one combined entry. Food processors and packagers are in a similar position to manufacturers. Since they handle raw materials, work-in-progress, and packaged food, both the record-keeping conditions and the storage conditions apply to them directly. They need to plan for Labeling systems that show manufacturing and expiry dates clearly, and warehouse layouts that push older or near-expiry stock out first. Warehousing and storage businesses are affected mainly by the second change. Even if they don't manufacture anything themselves, if they store raw materials or processed and packaged food on behalf of others, the FIFO/FEFO storage requirement applies to them. Whether the record-keeping condition applies depends on whether they also carry out any manufacturing activity. Non-manufacturing food business operators, such as pure traders and distributors who don't produce or process food themselves, get relief from the record-keeping condition since it is explicitly stated not to apply to non-manufacturing businesses. However, if they store processed or packaged food, the FIFO/FEFO storage rule can still apply to them. Pure retailers, like convenience stores and supermarkets selling packaged food directly to consumers, are the least affected group. Since they don't manufacture food, the record-keeping condition doesn't apply to them. Since the notification specifically exempts retailers from the FIFO/FEFO storage requirement, they are free from that obligation too. Restaurants and food service businesses need to check their own operations carefully. If they only serve food prepared fresh for immediate consumption, they may fall closer to non-manufacturing status. But if they process, prepare in bulk, or store ingredients and packaged food over time, both conditions are likely to apply. In practical terms, this means the businesses that must act immediately are manufacturers, processors, and storage operators. They need to redesign how they record daily production and raw material figures, and how they physically arrange stock so that older or soon-to-expire items are used or sold first. Retailers and non-manufacturing traders, on the other hand, get genuine regulatory relief here. They don't need to build new systems for these two specific conditions, which meaningfully reduces their overall compliance burden compared to businesses further up the supply chain. How Will Businesses Achieve Compliance? Compliance here is achievable and doesn't require expensive overhauls if done systematically. Here's a step-by-step approach. Step 1: Identify Your Business Category First, confirm whether you are a manufacturer, non-manufacturer, or retailer under FSSAI's definitions. This decides which of the two new conditions apply to you. Step 2: Update Record-Keeping Systems (For Manufacturers) Maintain a separate daily production register and a separate daily raw material utilization register. These can be kept physically or through software/ERP tools. FSSAI does not mandate a specific format, only that the records be maintained and kept distinct. Keep records dated, signed, and ready for inspection at any time. Step 3: Redesign Storage Practices Around FIFO/FEFO Label all raw materials and finished goods with the manufacturing date and expiry date. Arrange storage racks so older stock is placed in front and used first (FIFO). Where expiry dates vary due to different batches, prioritize the stock expiring soonest (FEFO). Use colour-coded labels, batch numbers, or barcode/QR systems for easy identification. Step 4: Train Staff Warehouse and production staff must understand FIFO/FEFO practically, not just in theory. Simple visual charts near storage areas help staff follow the system correctly every day. Step 5: Conduct Internal Audits Do monthly or quarterly internal checks to confirm records are being maintained, and FIFO/FEFO is actually being followed on the ground, not just on paper. Step 6: Keep Documentation Ready for FSSAI Inspection FSSAI officers can inspect these records during routine checks or license renewal. Non-compliance can lead to license suspension, cancellation, or penalties under the FSS Act. Compliance Checklist Table Action Item Applicable To Priority Separate production & raw material registers Manufacturers High Digital/manual record-keeping system Manufacturers High FIFO/FEFO labelling and layout Manufacturers, processors, and storage units High Staff training on FIFO/FEFO Manufacturers, processors, and storage units Medium Internal compliance audit All applicable FBOs Medium Confirm exemption status Non-manufacturers, retailers High Benefits for Businesses While this looks like a compliance requirement, it actually brings real business value: Reduced food wastage and spoilage- FIFO/FEFO ensures older and near-expiry stock is used first, directly cutting down losses and improving profit margins over time. Better inventory accuracy- separate, disciplined record-keeping gives businesses a clearer picture of raw material usage and production efficiency. Faster and easier recalls- clean, separated records let a business trace and recall affected batches quickly if a food safety issue ever arises, protecting brand reputation. Smoother FSSAI inspections and audits- Businesses with organised records face fewer queries, delays, or penalties during license renewal or surprise inspections. Improved buyer and export confidence- Large retail chains, export buyers, and institutional clients increasingly expect FIFO/FEFO discipline and clean documentation as part of vendor selection. Foundation for future certifications- These practices align closely with HACCP, ISO 22000, and other recognized food safety standards, making it easier to pursue certifications later. Lower risk of penalties- Proactive compliance reduces the chances of license suspension, cancellation, or fines due to missing or disorganized records. Stronger internal control- clear separation of data helps management track production efficiency and raw material costs more precisely, supporting better business decisions. Right Decision or Additional Burden? This is a fair question that every food business owner is asking.  The Case for the Right Decision The rule targets real, known risk areas, expired stock reaching consumers and untraceable production data both of which have caused food safety issues in India before. FSSAI has deliberately exempted non-manufacturers and retailers, showing the rule is proportionate rather than a blanket burden. FIFO/FEFO and separated records aren't new concepts either; most organized food businesses already follow some version of this informally, and the rule makes it a formal, enforceable requirement. The Case for Additional Burden Small and medium manufacturers without digital systems will need to invest time, and possibly money, in setting up proper record-keeping. There is no transition period, meaning businesses must comply immediately with limited preparation time. Physical redesign of storage areas for FIFO/FEFO can also involve real cost for businesses with large or complex inventories. The Balanced View Overall, this amendment leans more toward being a right regulatory decision than an unnecessary burden, because it directly targets food safety and traceability while keeping small non-manufacturing players and retailers exempted. The main challenge for businesses is the speed of compliance required, not the substance of the rule itself. Business Opportunities Created Every new compliance requirement also opens the door for new business and service opportunities. FSSAI compliance consulting and documentation support firms, inventory and warehouse management software providers, barcode/QR-based batch tracking system vendors, staff training and certification institutes, warehouse and storage rack solution providers, and food safety auditors can all find growing demand as businesses race to align with this amendment. Food businesses that act early and set up strong systems now will not only stay compliant but can also position themselves as more trustworthy suppliers to large retailers, exporters, and institutional buyers who prefer working with organized, well-documented vendors. Corpseed's Core Message Regulatory changes like the FSSAI Second Amendment Regulations, 2026, are not meant to slow businesses down; they are meant to build a safer, more transparent food ecosystem in India. The good news is that this amendment is practical, targeted, and workable, with sensible exemptions for smaller and non-manufacturing businesses. At Corpseed, our message to every food business is simple: don't wait for an inspection to discover a compliance gap. Understand exactly which part of this amendment applies to your business, set up your record-keeping and FIFO/FEFO systems correctly, and treat this as an opportunity to strengthen your food safety credibility, not just as another government formality. Whether you need help understanding your FSSAI license conditions, setting up compliant documentation systems, or getting expert guidance on the latest FSSAI regulations, staying proactive today is always cheaper and easier than fixing violations tomorrow.

Subject

Summary: The Formulation of the Intermediate Regulatory Framework in India India's formulation intermediate licensing framework sits at the intersection of two regulatory pillars: New Drugs and Clinical Trials (NDCT) Rules, 2019, under the Central Drugs Standard Control Organisation ( CDSCO ), which govern the approval of New Drugs, including all modified or sustained-release dosage forms. The Drugs and Cosmetics Act and applicable State Rules, under the State Licensing Authorities (SLAs), govern manufacturing licenses for standard, non-new-drug formulation intermediates. CDSCO's clarification, issued via Circular dated 24 June 2026, sits on top of these two pillars and tells manufacturers exactly which pillar applies to which type of intermediate. The formulation intermediate segment is an important part of India's pharma manufacturing chain: Formulation intermediates such as Directly Compressible (DC) granules, taste-masked granules, and modified-release granules/pellets are produced both by API manufacturers moving downstream and by specialised CDMOs. These intermediates feed directly into tableting and capsule-filling operations across India's domestic and export-facing pharma industry. Confusion between Central and State jurisdiction has, for years, led manufacturers to choose licensing routes based on convenience rather than correct classification. What Has Changed in 2026 - The Full Regulatory Clarification 1. New Drugs Including SR/ER/PR/DR Intermediates Now Require CDSCO Approval CDSCO checks the definition of "New Drug" from time to time and applies it strictly. The rule it relies on is Rule 2(1)(w) of the NDCT Rules, 2019 - this rule says that any modified or sustained release form of a drug is automatically treated as a New Drug, no matter how long that drug has been sold in its ordinary form. Here is the key thing: a granule or pellet that was earlier licensed at the State level might now require Central CDSCO approval, even if its active ingredient is decades old. This happens because the release mechanism itself - not the drug molecule - is what triggers New Drug status. With the 24 June 2026 clarification: All SR, ER, PR, and DR dosage forms - including Gastro-resistant Tablets/Capsules and Delayed Release (Enteric Coated) Tablets/Capsules - are deemed New Drugs. This deeming applies equally to the bulk formulation intermediate (the SR/ER/PR/DR granule or pellet itself), not only to the finished tablet or capsule. Manufacturers must file an application for the finished formulation together with a coordinated application for the formulation intermediate, both with CDSCO. 2. Standard Formulation Intermediates Remain on the SLA Track CDSCO has also clarified the other side of the line: Directly compressible granules and standard taste-masked granules that are not New Drugs continue to be licensed by the concerned State Licensing Authority. Applicants must submit the requisite data - stability, impurity, and blend uniformity information - directly to the SLA. 3. The Novel Excipient Override CDSCO has built in one important exception that applies regardless of release profile: If a formulation intermediate, of any kind, contains a new or novel excipient, CDSCO approval becomes mandatory. This overrides the SLA route entirely, even for an otherwise ordinary, immediate-release granule. 4. Single Point of Submission The circular closes by stating that the applicant must submit the application for the formulation intermediate - whether for import, manufacturing, or marketing - to CDSCO or to the SLA, as the case may be, based on the classification above. Implementation Timeline Summary Regulatory Milestone / Event Effective Date Transition Expectation 68th DCC Meeting recommendation on formulation intermediates 20 March 2026 Transition Expectation Official CDSCO Circular notification (F. No. ND-11012(17)/1/2026-eoffice) 24 June 2026 Treated as an immediate enforcement baseline - no formal grace period notified Recommended internal SKU/portfolio audit by manufacturers Immediate No statutory window; self-rectification is advisable before the next inspection Why CDSCO Issued This Clarification - The Core Need 1. Inconsistent State-Level Interpretation Created a Fragmented Market When formulation intermediates first began moving at scale between CDMOs, API makers, and formulation houses, there was no single, uniform understanding of where the SLA's authority ended and CDSCO's began. Because the underlying rule was open to interpretation, different states reached different conclusions for materially similar products. It was like a national vehicle safety authority allowing one state to certify an engine block while another state insisted the same engine needed national approval. Manufacturers found themselves choosing the state with the most convenient interpretation rather than the legally correct one. So the licensing system lost its consistency. The 2026 clarification fixes this by drawing one national line that every state and zonal office must now follow. 2. Therapeutic Risk Tied to Modified-Release Mechanisms Modified-release granules and pellets work because of a polymer coating or matrix structure that controls how and when the drug is released inside the body. Even a small failure in that mechanism at the bulk intermediate stage - before the product is even compressed or filled - can mean: Dose-dumping, where the full intended dose is released far too quickly, which is especially dangerous for narrow-therapeutic-index drugs Bioavailability variance, where batch-to-batch differences in coating change how much drug actually reaches the bloodstream Coating failure during compression or capsule filling, which can compromise the release mechanism before it even reaches finished-product testing CDSCO's job under the NDCT Rules, 2019, is to ensure that any product carrying this kind of therapeutic risk is evaluated centrally, with full clinical and technical scrutiny, rather than locally. 3. Closing the Gap Between API, Intermediate, and Finished Dose Previous regulatory oversight was confined to only the final tablet or capsule product. The actual intermediate drug substance in its bulk SR/ER/PR/DR form – that is, the process wherein the delivery system is made – had somehow eluded the same extent of oversight. This gap is bridged with the 2026 clarification. 4. Protecting the SLA Track From Misuse The novel excipient override has the same reason behind it; an otherwise conventional granule could turn out to be more risky after the addition of an untested excipient. The absence of the override would have made it possible for manufacturers to submit novel granules for approval under the SLA process due to their conventional release pattern. Impact on Indian Pharma Businesses in 2026 1. Large Formulation Manufacturers and CDMOs Modified-Release Portfolio: The companies that have specific multiparticulate or SR/ER pellet production lines will be directly impacted. Now, such companies will have to: Identify all SR/ER/PR/DR SKUs vis-a-vis the new CDSCO requirement Submit dual applications - one for the formulation and one for the intermediate – to CDSCO Re-align their SLA licensing for modified-release intermediates vis-a-vis the CDSCO requirement Standard Granule Portfolio: In the case of DC granules and taste-masked granules, large-scale manufacturers should: Improve upon stability, impurity, and blend uniformity data for a smooth SLA renewal Screen every excipient used across their portfolio for novelty status under Indian regulatory precedent 2. Specialised Pellet and Granule CDMOs This group sits at the centre of the circular's impact. Many CDMOs built their business specifically around multiparticulate SR/ER pellet manufacturing for client formulators. Impact: A CDMO supplying SR or ER pellets under an SLA-only license is now operating outside the correct regulatory channel. Pellets without the correct CDSCO clearance cannot legally be supplied for use in a finished formulation. To continue operating, these CDMOs must: Identify every pellet/granule SKU that falls under the SR/ER/PR/DR or novel excipient category. File the coordinated CDSCO application alongside their client formulator, since the rule expects parallel filing for the intermediate and the finished product. Update batch records to separate intermediate-stage data clearly from finished-dose data There is no formal grace period attached to this clarification, which makes early realignment important. 3. API Manufacturers Moving Downstream A growing number of API manufacturers have begun producing granulated or pelletised intermediates to capture more value in the supply chain. Impact: The moment an API is converted into an SR/ER/PR/DR granule or pellet, the entity is no longer simply an API producer for regulatory purposes - it becomes a formulation intermediate manufacturer. These manufacturers need to assess each downstream product individually against the CDSCO/SLA matrix rather than assuming their existing API manufacturing license is sufficient. 4. Importers of Formulation Intermediates India imports certain specialised pellets, coated granules, and excipient-based intermediates. Impact: Imported SR/ER/PR/DR intermediates require CDSCO clearance before import, manufacturing, or marketing. Importers need to verify, with their overseas suppliers, the declared release profile and excipient composition of every consignment before filing for clearance with the correct authority. 5. Finished-Dose Formulators Procuring Intermediates Externally Formulation houses that buy granules or pellets from third-party CDMOs rather than manufacturing them in-house must: Confirm that every externally sourced intermediate carries the correct license - SLA or CDSCO - before incorporating it into a finished product. Update vendor qualification and supplier audit checklists to specifically capture this classification Recognise that a finished formulation built on an incorrectly licensed intermediate carries the same compliance exposure as the intermediate itself. How Businesses Will Achieve Compliance Phase 1: Portfolio and SKU Classification Review (Do This Now) For each formulation intermediate, check and record: Whether it carries any SR, ER, PR, or DR release function Whether it is gastro-resistant or enteric-coated Whether its formula includes any excipient not previously used in an approved Indian product Compare each SKU against the CDSCO/SLA matrix to determine the correct licensing track Flag any SKU currently held under an SLA-only license that should be on the CDSCO track Phase 2: CDSCO Dual-Application Preparation (Where Needed) Compile release kinetics, dissolution, and stability data for the bulk intermediate Align this data with the finished-formulation dossier, since both applications are evaluated together Submit the coordinated application to CDSCO's New Drugs Division Phase 3: SLA Dossier Strengthening for Standard Intermediates Upgrade stability data, impurity profiling, and blend uniformity reports for DC and standard taste-masked granules File or renew the application with the concerned State Licensing Authority Phase 4: Excipient Novelty Screening Screen each excipient with respect to Indian regulatory precedent of usage, beyond just its worldwide approval. When novelty is established, prepare a safety package for CDSCO assessment Whenever feasible, screen excipient replacement that would maintain the SLA designation Phase 5: Inspection Readiness Amend batch manufacturing logs to differentiate intermediate stage data from final dose data Perform internal mock audits for the CDSCO/SLA classification prior to the next regular audit Benefits for Businesses After Implementation For Compliant Manufacturers and CDMOs Benefit Details Manufacturing Continuity Correctly licensed intermediates are not exposed to show-cause notices, suspensions, or batch seizures during inspection. Client Confidence Formulators can rely on CDMO-supplied intermediates without inheriting hidden licensing risk. Export Credibility A clean CDSCO/SLA compliance record supports export clearance and CoPP applications. M&A and Valuation Protection A documented, correctly classified intermediate portfolio avoids diligence flags during fundraising or acquisition Reduced Enforcement Exposure Proactive realignment avoids reactive remediation under inspection pressure, which is typically costlier and faster-paced For Patients and the Healthcare System Benefit Details Reduced Dose-Dumping Risk Central evaluation of release mechanisms at the bulk intermediate stage reduces the risk of premature or excessive drug release. More Consistent Bioavailability Centrally reviewed SR/ER/PR/DR intermediates are evaluated for batch-to-batch consistency before reaching patients. Greater Confidence in Modified-Release Products A clearer licensing line reduces the chance of substandard modified-release products entering the supply chain through SLA-only routes. Is This the Right Decision or an Additional Burden? Why It Is the Right Decision Aspect Reason Closes a Genuine Regulatory Gap Bulk SR/ER/PR/DR intermediates carry real therapeutic risk that was not consistently scrutinised at the intermediate stage. Restores National Uniformity A single CDSCO/SLA classification line replaces inconsistent state-by-state interpretation. Strengthens the Novel Excipient Safety Net The override ensures untested excipients cannot bypass central safety review by hiding inside a conventional-looking product. Backed by Statutory Definition The clarification applies an existing rule - Rule 2(1)(w) of the NDCT Rules, 2019 - rather than introducing new, untested obligations. Where It Adds Burden Concern Excipient Re-Screening Effort No Formal Grace Period Because the circular is clarificatory, manufacturers do not have a notified transition window before enforcement applies. Dual-Filing Cost and Complexity Coordinated CDSCO applications for both the intermediate and the finished formulation require more data and more time than a single SLA filing. CDMO Realignment Pressure Specialised pellet/granule CDMOs built around SLA licensing now face an urgent need to refile under CDSCO. Excipient Re-Screening Effort Companies must re-examine excipients across their entire portfolio for Indian novelty status, even where global approval already exists. Business Opportunities Created 1. CDSCO Dual-Application Filing Services (Core Opportunity for Corpseed) Service Target Clients CDSCO New Drug permission for SR/ER/PR/DR formulations and bulk intermediates Formulation manufacturers and CDMOs Coordinated dual-dossier drafting (finished formulation + intermediate) Formulators working with external pellet/granule CDMOs Excipient novelty screening and safety dossier preparation R&D teams and ingredient importers SLA license filing and renewal for standard granules DC granule and taste-masked granule manufacturers Import documentation and CDSCO port office liaison Importers of formulation intermediates Annual compliance monitoring and SKU re-classification All manufacturers holding mixed CDSCO/SLA portfolios 2. SKU Classification and Portfolio Audit Services Reviewing every formulation intermediate SKU against the CDSCO/SLA matrix Identifying SKUs currently under SLA licenses that should be reclassified to the CDSCO track Corpseed can manage the full classification process for clients, including: Reviewing release-mechanism data for each product Screening excipients against Indian regulatory precedent Flagging high-risk SKUs requiring urgent CDSCO filing 3. Inspection Readiness Audits for CMOs and Formulators CMOs and formulators face show cause notices and batch seizures in case the intermediate licensing does not coincide with the present CDSCO categorization. Corpseed will audit intermediate licensing for: CDSCO authorization for SR/ER/PR/DR pellets & granules SLA authorization for standard DC and taste-masked granules Apply for approval from CDSCO/SLA prior to the next audit cycle 4. Technical and Regulatory Advisory for Smaller CDMOs Not all smaller pellet and granule makers can afford to have an in-house regulatory team. What they need is affordable and targeted assistance for: Evaluating if their current SKUs qualify for the CDSCO or the SLA path Preparing the comprehensive application data package Answering any queries that may arise from CDSCO or SLA during the dossier review Corpseed can provide such assistance through defined advisory packages 5. M&A and Investment Due Diligence Support Pharma companies undergoing fundraising, acquisition, or licensing-out transactions need a clean intermediate licensing record. Corpseed can: Compile a classification report covering every formulation intermediate in the target company's portfolio Identify and quantify any CDSCO/SLA misclassification risk ahead of due diligence Support remediation before disclosure to counterparties Corpseed's Core Message for This Service Given Corpseed's existing work in pharmaceutical regulatory compliance, CDSCO's 2026 formulation intermediate clarification is a direct, time-sensitive opportunity. Because the circular operates as an immediate enforcement baseline rather than a future-dated rule, manufacturers and CDMOs holding SLA-only licenses for SR/ER/PR/DR intermediates are already exposed, with no formal grace period to fall back on. This urgency, combined with a clear and well-defined service scope, makes CDSCO/SLA dual-track compliance a high-demand service for Corpseed.

Subject

Summary: This AYUSH notification brings into force, from 1 July 2026, the AYUSH‑related amendments to the Drugs and Cosmetics Act, 1940, that were already enacted in the Jan Vishwas (Amendment of Provisions) Act, 2026. The real policy change is in Jan Vishwas; this notification is the “start button.” What exactly does this notification do? Issuing authority: Ministry of Ayush, New Delhi. Legal basis: Sub‑section (2) of section 1 of the Jan Vishwas (Amendment of Provisions) Act, 2026 (Act 8 of 2026). Content: It appoints 1 July 2026 as the date from which those provisions of Jan Vishwas 2026 that amend the Drugs and Cosmetics Act, 1940, at serial numbers 8 (H) and (I) will come into force. Effect: From 1 July 2026 onwards, the amended penalty/ compliance framework for AYUSH‑related provisions of the Drugs and Cosmetics Act becomes legally operational. So, the “policy” you are asking about is actually the cluster of D&C Act amendments for AYUSH that Jan Vishwas 2026 introduced; this notification activates them for AYUSH. What Jan Vishwas does to the Drugs and Cosmetics Act? While the notification doesn’t list the clauses, Jan Vishwas 2026 is broadly a “decriminalisation and rationalisation” law. For the Drugs and Cosmetics Act, especially for AYUSH drugs, it typically does things like: Convert certain minor, technical, or procedural offences from criminal offences (with possible imprisonment) into monetary penalties/compounding offences. Rationalise penalty amounts, making them proportionate and escalating with seriousness/repetition. Introduce or clarify adjudication mechanisms (designated officers who can impose penalties), reducing routine police/court involvement. In some cases, increase the maximum fines for serious repeat or fraudulent offences to maintain deterrence while reducing the use of imprisonment for minor lapses. The exact sub‑clauses (8(H) and 8(I)) will be specific amendments to selected sections of the D&C Act dealing with AYUSH products typically around misbranding, labelling, minor licence violations, and record‑keeping. Impact on AYUSH businesses and compliance How businesses will be compliant? For AYUSH manufacturers, marketers, and importers: Substantive quality, safety, GMP, and labelling conditions under the Drugs and Cosmetics Act and its Rules do not get diluted. Those standards remain in place. What changes is the nature of consequences for certain categories of non‑compliance: Many minor lapses will now attract a monetary penalty imposed by a designated authority, rather than prosecution in criminal courts. Some offences may become compoundable, allowing payment of a fixed sum to settle the matter without a prolonged case. Businesses should therefore: Map their existing compliance obligations (licences, GMP, labelling, renewals, reporting). Understand which sections of the D&C Act now have revised penalty structures and plan internal SOPs accordingly. Build internal systems for quick response to show‑cause notices and adjudication proceedings, to avoid higher penalties for non‑cooperation or repeat violations. Overall, day‑to‑day compliance remains the same the rules you have to follow are not relaxed but the enforcement mechanism is more predictable and less criminalised. Who benefits the most? AYUSH MSMEs and mid‑size manufacturers For small and mid‑size Ayurvedic, Siddha, Unani, Homoeopathy, and other AYUSH drug manufacturers, the biggest fear earlier was criminal prosecution (including potential imprisonment) even for relatively minor, first‑time technical lapses. Moving these to monetary penalties and adjudication reduces business risk and personal risk for directors, making the regulatory environment less intimidating and more in line with ease‑of‑doing‑business goals. Start‑ups and new AYUSH brands Entrepreneurs launching new AYUSH formulations, wellness products, and exports will perceive the lower criminal risk when entering a regulated space. Easier resolution of minor issues (labelling mistakes, delays in renewals, non‑material documentation errors) will encourage experimentation and formalisation, instead of staying in the grey market. Regulators and enforcement agencies State Licensing Authorities and AYUSH regulators get clearer powers and processes for adjudicating the minor offences internally, without overloading the criminal courts with routine compliance cases. This can improve consistency and speed of enforcement and allow them to focus criminal prosecution on truly serious offences adulteration, spurious drugs, serious public‑health threats. Who may be negatively impacted or lose out? Businesses relying on low‑compliance, grey‑market practices Firms that benefited from regulatory paralysis or inconsistent prosecution might find the new system more predictable and more strictly enforced because monetary penalties are easier to impose than criminal trials. If Jan Vishwas has increased fines for certain repeat or serious violations, chronic violators could see higher financial exposure than under a weakly enforced criminal system. Very small, informal players who don’t regularise The law expects businesses to be formally licensed, documented, and reachable for adjudication and penalty orders. Informal, unregistered AYUSH manufacturers or packers might face sharper consequences if caught, including higher penalties or escalated action if they fail to engage with the adjudication process. Overall, well‑intentioned, compliant businesses gain; those that depended on informal arrangements and lax enforcement lose ground. Why AYUSH / Government brought this policy? Two main reasons: 1. Jan Vishwas mission: This is part of a cross‑Ministry project to make 30+ central laws more business‑friendly by: Reducing criminalisation of economic and procedural offences. Increasing reliance on civil penalties and administrative adjudication. 2. AYUSH sector-specific needs: The sector has a very large number of small and medium players; heavy criminal provisions deter formalisation and investment. There was a need to separate minor lapses (documentation, small label deficiencies) from serious threats (spurious/adulterated drugs), so that enforcement can be proportional and credible. India wants to promote AYUSH exports and wellness tourism; a rational, transparent penalty regime is important for investor and international buyer confidence. Impact on the Indian economy 1. Positive effects Ease of doing business: Lower criminal risk also reduces the perceived risk premium for operating in the AYUSH pharmaceutical and wellness sector. That can encourage the formalisation and entry of new, better‑capitalised players. Better utilisation of regulatory resources: Courts and inspectors can also focus their limited bandwidth on serious offences and systemic quality lapses, rather than chasing minor paperwork errors. Export potential: A modern, graded enforcement framework makes it easier to demonstrate to international partners that India is serious about quality and also has predictable, rule‑based enforcement. 2. Possible downsides/concerns If penalties are set too low or adjudication is too lenient, there is a theoretical risk of some players treating fines as a “cost of doing business” and not improving quality. Much will depend on how the AYUSH and drug regulators implement the new powers quality of inspections, fairness, and transparency in adjudication. On balance, the likely macro impact is moderately positive: reduced compliance anxiety, better targeting of enforcement, and improved investment climate in AYUSH pharmaceuticals and wellness products. Does this help business conditions, transparency, and product quality? Business Conditions: Yes, there are fewer criminal triggers, more fines are used, and minor cases are closed more quickly. Legal overhead and ambiguity are decreased as a result. Openness: Compared to ad hoc criminal complaints, Jan Vishwas can improve openness to the extent that it mandates specified punishment slabs, designated adjudicating personnel, and prescribed procedures. Product caliber: GMP, standards, and laboratory testing are examples of direct quality criteria that have not changed and are still stringent. Day-to-day compliance can be indirectly increased by making it simpler and quicker to impose sanctions for small transgressions. However, how regulators prioritize and keep an eye on significant quality issues will determine the true quality benefit.  Is this the right decision or an additional burden? Why it’s largely the right decision? It does not add new substantive obligations on AYUSH businesses; it changes how non‑compliance is handled. Moving away from the criminalisation of minor breaches, it aligns with global practice and with India’s own ease‑of‑doing‑business agenda. It should reduce fear among genuine entrepreneurs and attract more formal, compliant capital into AYUSH. Where burdens still exist? AYUSH businesses must still manage complex compliance under the D&C Act and Rules. They now also need to understand the new penalty and adjudication system, respond properly to notices, and manage internal documentation more carefully. If regulators become more active (because penalties are easier to impose), some players may feel more pressure than before, even though the nature of that pressure is civil rather than criminal. Overall, this is not a dark policy; it is a technical, enabling step that activates decriminalisation and rationalisation of penalties from 1 July 2026. Implementation date and business opportunities Implementation date: The notification appoints 1 July 2026 as the date on which the AYUSH‑related amendments to the Drugs and Cosmetics Act under Jan Vishwas 2026 come into force. Opportunities: Compliance and legal advisory: Law firms, consultants, and compliance service providers can help AYUSH companies re‑map risks under the new regime, design SOPs, and train staff. Quality and GMP upgrade services: With the easier enforcement, regulators may push more firmly on quality consultants and labs supporting GMP, validation, and testing gains. Consolidation and investment: A clearer, less criminalised regime can facilitate consolidation of small plants, private equity investment, and joint ventures with global wellness/pharma companies. RegTech tools: Digital tools for tracking licences, inspections, notices, and penalty status can help AYUSH manufacturers stay ahead of compliance.